On Nov. 1, Pfizer issued a press release about an investigational vaccine for pregnant women the company said will protect babies from respiratory syncytial virus (RSV). Not coincidentally, RSV is the latest viral bugaboo to hit the headlines, with frantic news accounts of “overwhelmed” hospitals sounding eerily reminiscent of the early coronavirus fear-mongering.
Buoyed by the successful global marketing of its COVID-19 jabs — an estimated 49% of pregnant women worldwide reportedly views the vaccines favorably and almost 1 in 4 pregnant women in the U.S. took them — Pfizer is hoping to hit another home run with the RSV vaccine. The vaccine maker said it intends to seek U.S. Food and Drug Administration (FDA) approval by the end of the year.
The FDA, meanwhile, has been busy handing out “Breakthrough Therapy” designations to Pfizer as if they were papal dispensations, signaling a regulatory willingness to speed up approval not only for Pfizer’s RSV vaccine but also for a maternal Group B Streptococcus (GBS) vaccine the company is developing. To this expedient end, the FDA allowed Pfizer to “stop the [RSV] study short,” halting enrollment at about 7,400 participants — though the trial was supposed to involve 10,000 pregnant women.